PROCEDURE AND RECORD MAINTAIN OF LOAN AND LICENCE BASIS JOB WORK

[nandankumar roy]

DEAR SIR,

WE ARE NOW GOING TO LOAN AND LICENCE BASIS JOB WORK FOR MANUFACTURING OF PHARMA PRODUCTS.PLEASE HELP WHAT WE HAVE  TO FOLLOW PROCEDURES AND RECORD MAINTAINANCE FOR THAT JOB WORK.

NANDANROY

AI Summary

Pharmaceutical Manufacturing on Loan License: Rule 138-A Compliance and Record-Keeping Requirements Explained A query was raised regarding the procedures and record maintenance for conducting job work on a loan and license basis for manufacturing pharmaceutical products. The response outlined that under the Drugs and Cosmetics Act, loan licensees are considered manufacturers. An application must be submitted under Rule 138-A of the Drugs and Cosmetics Rules, 1945, with prior notification to the excise department. Raw materials from loan licensees should be stored separately, with clearances made upon excise duty payment and reported in ER 1 returns. A separate register for materials and manufactured goods is necessary, production must follow input-output norms, and a prior agreement with the loan licensee is required.